Everting transcatheter valve and methods

Abstract

A method can comprise: positioning a prosthetic heart valve in a collapsed configuration at an implantation site. In some examples, the prosthetic heart valve can comprise: a multi-part frame having a body frame and a leaflet frame, and at least one leaflet coupled to the multi-part frame. In some examples, the prosthetic heart valve can be expandable between the collapsed configuration and an expanded configuration. The method can further comprise expanding the prosthetic heart valve to the expanded configuration at the implantation site, transitioning the multi-part frame of the prosthetic heart valve from a non-everted configuration to an everted configuration, and securing the prosthetic heart valve at the implantation site.

We claim: 
     
         1 . A method comprising:
 positioning a prosthetic heart valve in a collapsed configuration at an implantation site, wherein:
 the prosthetic heart valve comprises:
 a multi-part frame having a body frame and a leaflet frame; and 
 at least one leaflet coupled to the leaflet frame, wherein the prosthetic heart valve is expandable between the collapsed configuration and an expanded configuration; 
 
   expanding the prosthetic heart valve to the expanded configuration at the implantation site;   transitioning the multi-part frame of the prosthetic heart valve from a non-everted configuration to an everted configuration; and   securing the prosthetic heart valve at the implantation site.   
     
     
         2 . The method of  claim 1 , wherein transitioning the multi-part frame of the prosthetic heart valve to the everted configuration comprises everting the leaflet frame relative to the body frame. 
     
     
         3 . The method of  claim 1 , wherein transitioning the multi-part frame of the prosthetic heart valve from the non-everted configuration to the everted configuration comprises moving an everter from a first position to a second position. 
     
     
         4 . The method of  claim 3 , wherein:
 the leaflet frame comprises a plurality of posts, and   the everter is configured to fit over the plurality of posts when the multi-part frame is in the non-everted configuration.   
     
     
         5 . The method of  claim 4 , wherein the plurality of posts are not in direct contact with the everter when the multi-part frame is in the everted configuration and when the everter is in the second position. 
     
     
         6 . The method of  claim 1 , wherein the leaflet frame resides outside the body frame when the multi-part frame is in the non-everted configuration. 
     
     
         7 . The method of  claim 6 , wherein the body frame extends coaxially, adjacent to, and spaced apart from the leaflet frame when the multi-part frame is in the non-everted configuration. 
     
     
         8 . A method comprising:
 positioning a prosthetic heart valve at an implantation site, wherein the prosthetic heart valve comprises:
 a frame having a body frame coupled to a leaflet frame; and 
 one or more leaflets coupled to the leaflet frame; 
   expanding the prosthetic heart valve at the implantation site from a collapsed configuration to an expanded configuration; and   moving an everter relative to the frame from a distal position to a proximal position to transition the leaflet frame from a non-everted configuration to an everted configuration.   
     
     
         9 . The method of  claim 8 , wherein the leaflet frame further comprises a plurality of posts that extend in a distal direction of the frame when the leaflet frame is in the non-everted configuration. 
     
     
         10 . The method of  claim 9 , wherein the everter is configured to fit over the plurality of posts when the leaflet frame is in the non-everted configuration. 
     
     
         11 . The method of  claim 9 , wherein the everter comprises an annular structure that radially compresses the plurality of posts when the leaflet frame is in the non-everted configuration. 
     
     
         12 . The method of  claim 8 , wherein the body frame extends coaxially, adjacent to, and spaced apart from the leaflet frame when the frame is in the non-everted configuration. 
     
     
         13 . The method of  claim 8 , wherein the leaflet frame resides at least partially coaxially disposed within the body frame when the frame is in the everted configuration. 
     
     
         14 . A method comprising:
 expanding a prosthetic heart valve at an implantation site, wherein:
 the prosthetic heart valve comprises a frame that includes a first portion coupled to a second portion; 
   transitioning the frame from a non-everted configuration to an everted configuration by everting the second portion relative to the first portion; and   securing the prosthetic heart valve at the implantation site.   
     
     
         15 . The method of  claim 14 , wherein everting the second portion relative to the first portion comprises moving an everter from a first position to a second position relative to the prosthetic heart valve. 
     
     
         16 . The method of  claim 15 , wherein:
 the first position is distally adjacent a distal end of the prosthetic heart valve, and   the second position is proximally disposed relative to a proximal end of the prosthetic heart valve.   
     
     
         17 . The method of  claim 15 , wherein:
 the prosthetic heart valve defines a valve orifice, and   the everter is moved through the valve orifice from the first position to the second position.   
     
     
         18 . The method of  claim 14 , wherein:
 the first portion and the second portion are indirectly coupled by a film extending between the first portion and the second portion, and   the film defines a fold region disposed between the first portion and the second portion.   
     
     
         19 . The method of  claim 18 , wherein everting the second portion relative to the first portion comprises rotating the second portion about the fold region relative to the first portion. 
     
     
         20 . The method of  claim 14 , wherein everting the second portion relative to the first portion comprises moving the second portion in a proximal direction relative to the first portion. 
     
     
         21 . The method of  claim 14 , wherein the first portion extends coaxially, adjacent to, and spaced apart from the second portion when the frame is in the non-everted configuration.